| CTRI Number |
CTRI/2025/07/091720 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
MIXED METHODOLOGY |
| Study Design |
Other |
|
Public Title of Study
|
Child birth experience of mothers |
|
Scientific Title of Study
|
Mixed Methodology on Comprehensive Child Birth Experience of mothers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| M8/F219/2025 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr P VADIVUKKARASI |
| Designation |
Associate Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
COLLEGE OF NURSING AIIMS, Changsari, Guwahati, Assam, India, 781101 Kamrup ASSAM 781037 India |
| Phone |
07046593297 |
| Fax |
|
| Email |
krishraghav2010@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr P VADIVUKKARASI |
| Designation |
Associate Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
College of Nursing, 1st Floor, 1st Room AIIMS, Changsari, Guwahati, Assam, India, 781101 Kamrup ASSAM 781037 India |
| Phone |
07046593297 |
| Fax |
|
| Email |
krishraghav2010@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr P VADIVUKKARASI |
| Designation |
Associate Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
COLLEGE OF NURSING, 1st Floor, Room No.6 AIIMS, Chansari, Guwahati, Assam, India, 781101 Kamrup ASSAM 781037 India |
| Phone |
07046593297 |
| Fax |
|
| Email |
krishraghav2010@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS, Changsari, Guwahati, Assam, India, 781101 |
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
COLLEGE OF NURSING, AIIMS,
Changsari, Guwahati, Assam, India, 781101 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr P VADIVUKKARASI |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
AIIMS,College of Nursing, Changsari, Guwahati, Assam, India, 781011 Kamrup ASSAM |
07046593297
krishraghav2010@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ALL INDIA INSTITUTE OF MEDICAL SCUENCES (AIIMS), GUWAHATI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
POSTNATAL MOTHERS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Postnatal mothers had both spontaneous and assisted vaginal delivery in AIIMS, Guwahati
Postnatal mothers within three days of their delivery
Postnatal mothers willing to participate
Postnatal mothers able to understand and communicate in Hindi, Assamese & English
|
|
| ExclusionCriteria |
| Details |
Postnatal mothers with still birth or intra uterine death
Postnatal mothers given consent and later do not cooperate
Postnatal mothers with mental disorders
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Explore the Comprehensive Child birth experiences |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Parturition is otherwise known as Child birth. Childbirth is a profound and transformative experience, marking the arrival of a new life and a significant moment in the lives of parents. For many, it involves a mix of excitement, joy, anticipation, and sometimes fear or uncertainty. The process of childbirth itself is both physically demanding and emotionally charged, often requiring patience, support, and resilience. From the moment labor begins, through the intense physical sensations of contractions, to the final push that brings a baby into the world, childbirth is a unique journey for each individual. The experience can vary widely depending on many factors, such as the birthing method (vaginal delivery, cesarean section), the presence of complications, personal preferences, and the emotional and physical support available. Childbirth can evoke powerful emotions, ranging from elation and awe at the miracle of life to the relief and exhaustion that follows. It is a pivotal life event that shapes not only the lives of the parents but also their bond with the newborn and their growing family. Ultimately, while every childbirth experience is different, it is an experience that is often remembered as one of the most significant and life-changing events of a person’s life. |